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510(k) Data Aggregation

    K Number
    K252106
    Device Name
    External Fixation Mini Rail System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2025-09-30

    (89 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K232838,K202143,K162032
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The External Fixation Mini Rail System is intended for external fixation and is indicated for stabilization of fractures and osteotomy, foot arthrodesis, adult and pediatric leg lengthening, and correction of bone deformity in the lower extremities. The External Fixation Mini Rail System is intended to be used in pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

    Device Description

    The External Fixation Mini Rail System consists of pins, rail, wires and pins clamps. The mini rail frame serves as the structural base for fixation distraction. The pin clamps allow rotational and translational positioning of bone segments. The system is meant to offer a solution for compression and gradual distraction of the metatarsals and 1st metatarsophalangeal (MTP) joint. The system also includes instrumentation for implantation such as wires, drivers, sawblades, wrenches, templates and cut guides.

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